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YY/T 0616.1-2016 English PDF (YYT0616.1-2016)

YY/T 0616.1-2016 English PDF (YYT0616.1-2016)

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YY/T 0616.1-2016: Medical gloves for single use--Part 1: Requirements and testing for biological evaluation

This Part of YY/T 0616 specifies the requirements for the biological safety evaluation of medical gloves for single use, and gives the requirements for the labeling and disclosure of information for the test methods used. This Part applies to the biological safety evaluation of medical gloves for single use.
YY/T 0616.1-2016
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE REPUBLIC OF CHINA
ICS 11.040.01
C 30
Replacing YY/T 0616.1-2007
Medical gloves for single use - Part 1.
Requirements and testing for biological evaluation
ISSUED ON. JANUARY 26, 2016
IMPLEMENTED ON. JANUARY 01, 2017
Issued by. China Food and Drug Administration
Table of Contents
Foreword ... 3
Introduction ... 4
1 Scope ... 5
2 Normative references ... 5
3 Terms and definitions ... 5
4 Requirements... 7
5 Test methods ... 9
Annex A (normative) Method for determining water-soluble proteins of natural rubber gloves by improved Lowry analytical method ... 11
Annex B (informative) Immunoassay method for natural rubber latex allergens ... 23
Annex C (informative) Determination of amino acids (AAA) by high performance liquid chromatography (HPLC) ... 28
Bibliography ... 37
Foreword
YY/T 0616 ?€?Medical gloves for single use?€? consists of the following parts. - Part 1. Requirements and testing for biological evaluation;
- Part 2. Requirements and testing for shelf life determination.
This Part is Part 1 of YY/T0616.
This Part was drafted in accordance with the rules given in GB/T 1.1-2009. This Part replaces YY/T 0616-2007 ?€?Medical gloves for single use -
Requirements and testing for biological evaluation?€?. Compared with YY/T 0616- 2007, the main technical changes are as follows.
- MODIFY the standard name;
- MODIFY and SUPPLEMENT ?€?3 Terms and definitions?€?;
- ADD ?€?4.4 Powder, 4.5 Leachable proteins and 4.6 Labeling";
- MODIFY Annex B Immunoassay method for natural rubber latex allergens; - MODIFY Annex C Determination of amino acids (AAA) by high performance liquid chromatography (HPLC);
- DELETE Annex D Terms.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. The drafting authority of this document shall not be held responsible for identifying any or all such patent rights.
This Part is under the jurisdiction of China Food and Drug Administration Jinan Medical Device Quality Supervision and Inspection Center.
Drafting organizations of this Part. Shandong Medical Device Quality Inspection Center, Beijing Institute of Medical Device Testing, Jiangsu Institute of Medical Device Testing.
Main drafters of this Part. Hao Shubin, Liu Bin, Liu Xiaoshuai, Huang Yongfu, Lin Hongsai, Gao Jingxian, Jin Meng.
The historical edition of the standard replaced by this Part is as follows. - YY/T 0616-2007.
Introduction
In recent years, it is often reported that latex products cause adverse reactions to medical personnel and patients due to the presence of latex proteins. The adverse reactions due to residues such as chemicals, lubricants, sterilized residues (ethylene oxide) and pyrogens are also described in scientific bibliographies. Among them, the most commonly reported are adverse
reactions caused by natural rubber latex gloves, but gloves made of other polymers can also cause some adverse reactions.
GB/T 16886 series of standards specifies the requirements and test methods for biological evaluation of medical devices. However, adverse reactions (such as immediate hypersensitivity reactions) caused by the use of medical gloves are not involved. These adverse reactions are mainly caused by the specific allergens present in the gloves. The factors for these reaction risks are. a) the time and frequency of skin contact with the gloves;
b) the mucous membranes and the skin (especially when incomplete) are in direct contact with allergens [Translator note. There is another nick-name in Chinese] and inhalation particles;
c) how closely the gloves are applied to the skin during use.
FDA believes that the powder in gloves is also a source of danger, which may lead to foreign body reaction and granuloma formation, and may also lead to irritant dermatitis, type IV allergy, etc. It may be used as an airborne carrier for natural latex to cause users allergy.
This Part gives the requirements and test methods for the biological safety evaluation of medical gloves, which is taken as a part of the risk analysis process according to YY/T 0316 and GB/T 16886.
Medical gloves for single use - Part 1.
Requirements and testing for biological evaluation
1 Scope
This Part of YY/T 0616 specifies the requirements for the biological safety evaluation of medical gloves for single use, and gives the requirements for the labeling and disclosure of information for the test methods used.
This Part applies to the biological safety evaluation of medical gloves for single use.
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
GB/T 16886 (all parts) Biological evaluation of medical devices
GB/T 21869 Medical gloves - Determination of removable surface powder
YY/T 0316 Medical devices - Application of risk management to medical
devices (YY/T 0316-2008, ISO 14971.2007, IDT)
YY/T 0466.1 Medical devices - Symbols to be used with medical device
labels labelling and information to be supplied - Part 1. General requirements (YY/T 0466.1-2009, ISO 15223-1.2007, IDT)
Pharmacopoeia of the PEOPLE Republic of China (2010 edition)
ISO 7000 Graphical symbols for use on equipment - Index and synopsis
3 Terms and definitions
For the purpose of this document, the following terms and definitions apply. 3.1
chemicals
Substances that are added or formed during or after any process of the
production process. These substances can be detected from the final product. NOTE. These chemicals include lubricant, chemical coating and sterilant. Chemicals are often used during glove processing and some of them are known to cause type IV hypersensitivity. The type, the residual amount and the final form of presence of the chemicals added are uncertain.
3.2
endotoxins
Lipopolysaccharide that is derived from the of the outer structure of the Gram- negative bacterial cell membrane.
NOTE. Endotoxin is a pyrogen. Endotoxins may come from the raw material of gloves, especially the water used in the process of production, and bacteria contamination caused by manual processing.
3.3
powder
Under this test condition, all water-insoluble substances that can be removed by washing with water on the glove surface.
[GB/T 21869-2008, definition 3.1]
NOTE. Including intentionally added powder and other processing aids or unintentionally randomly present substances, these substances can easily be separated from the surface of gloves. This Part specifies that any glove containing less than or equal to 2 mg of powder is a powder-free glove, and a glove with more than 2 mg of powder is a powdered glove (see 4.4 for requirements).
3.4
process limit
The possible maximum value of a confirmed process.
3.5
allergenic proteins
Proteins that can cause type I allergic reactions.
3.6
leachable proteins
Water-soluble proteins and peptides with different molecular weights that can be leached from the final product.
3.7
pyrogens
Substances that make rabbits fever. These substances may also cause the human body to have a fever reaction and other adverse reactions.
4 Requirements
4.1 General
Medical gloves for single use shall be evaluated according to GB/T 16886. GB/T 16886.1 describes the general principle of biological evaluation of medical devices and is used to select suitable tests described in other parts. Risk management shall be conducted in accordance with YY/T 0316.
4.2 Chemicals
Gloves shall not contain or be coated with talcum powder (magnesium silicate). If technically feasible, it shall avoid using chemicals known to have allergenicity. Whenever feasible, it shall use GB/T 16886.17 to determine the allowable limits for leachable residual chemicals and meet these limits. If infeasible, the residual chemical level shall be ?€?ALARP?€? [ALARP (As Low As Reasonably Practicable) - See YY/T 0316].
If required, the manufacturer shall indicate the chemicals added during the production process or known in the product, such as accelerators, antioxidants and bactericides, which are known to have adverse health effects based on the existing bibliography.
4.3 Endotoxins
If the glove is marked with ?€?low endotoxin content?€?, the manufacturer shall monitor the endotoxin contamination of the sterile glove according to the test method specified in 5.1. For gloves with such marking, the endotoxin content of each pair of gloves shall not exceed 20 EU.
4.4 Powder
For powder-free gloves, the total amount of residual powder determined
according to the test method of 5.2 shall not exceed 2 mg per glove. Any glove with a powder content of more than 2 mg is powdered gloves.
4.5 Leachable proteins
The manufacturer shall monitor the process limits of soluble proteins in gloves containing natural rubber latex according to the test method specified in 5.3. It shall retain the test result document. It shall be able to provide test results and test methods used as required.
The leachable protein level shall be ?€?As Low As Reasonably Practicable?€? (ALARP).
NOTE. For allergenic proteins, this Part specifies the similar methods for measuring allergens (such as leachable proteins). There is no direct correlation between leachable proteins and allergens. Annex B describes the under-
development quantitative testing methods for allergenic proteins.
4.6 Labelling
In addition to the relevant symbols given in YY/T 0466.1, the following requirements apply.
a) Medical gloves containing natural rubber latex shall have at least the following symbol on the smallest packaging unit, see Figure 1 (symbol
2725 of ISO 7000 gives the general requirements for the application of
this symbol);
Figure 1 -- Symbol for products containing natural rubber latex
b) In addition to the symbol, the label shall also include the following warning statement or equivalent warning statement.
?€?(The product) contains natural rubber latex that may cause allergic
reactions (including allergic response),?€?;
c) The label shall prominently give a statement as to whether the glove contains powder;
d) Sterile powdered gloves shall be marked with the following or equivalent textual description.
?€?CAUTION. Surface powders shall be aseptically removed prior to surgery to minimize the risk of adverse tissue reactions.?€?;
NOTE 1. This precaution may be given on the inner wrap.
e) For any medical glove containing natural rubber latex, the product label shall not contain.
- any description that indicates relative safety, such as hypo-allergenicity or low protein;
- any unreasonable description of the present allergens;
f) The manufacturers shall, if labeled to contain proteins, indicate the process limits determined according to the specifications of 5.3.
NOTE 2. It is not allowed to mark that the protein content is below 50 ??g/g. Due to variability in the expected manufacturing process and inter-laboratory test results, the nominally low protein content is considered to be unreliable. 5 Test methods
5.1 Endotoxins
Unless unresolvable interference occurs in the LAL test, the method shall be selected, confirmed and used according to the bacterial endotoxin test specified in the Chinese Pharmacopoeia (hereinafter referred to as the Chinese
Pharmacopoeia). The results are expressed in endotoxin units (EU) containing in each pair of gloves.
NOTE 1. When unresolvable interference occurs in the LAL test, the bacterial endotoxin level cannot be accurately measured.
The recommended minimum number of test gloves and the testing amount are determined according to the batch. When the batch is less than 30 pairs, the sampling amount is 2 pairs; when the batch is between 30 and 100 pairs, the sampling amount is 3 pairs; when the batch is more than 100 pairs, the
sampling amount is 3 %, but the maximum sampling amount is 10 pairs for each batch.
The outer surface of each pair of gloves, in such a way that all the outer surfaces of the gloves are in contact with the extraction medium, is leached with 40 mL of endotoxin-free water (the bacterial endotoxin test water specified in the Chinese Pharmacopoeia) at 37 ??C to 40 ??C for 40 min to 60 min. When necessary, the leachate is centrifuged at 2000 g for 15 min to remove
particulates. After centrifugation, remove the liquid components and carry out the endotoxin test immediately.
NOTE 2. Other existing accepted endotoxin analysis methods, only have been confirmed and relevant to the baseline method specified in this Part, can also be used for routine quality control.
5.2 Powder
It shall use the method described in GB/T 21869 to determine the powder residue.
5.3 Leachable proteins
The method for determining leachable proteins shall use the improved Lowry method given in Annex A or the method confirmed by the improved Lowry
method.
NOTE 1. The immunoassay method for proteins in Annex B has not been confirmed by the improved Lowry method, but it can be correlated with clinical response data. NOTE 2. Annex C gives examples of a confirmed analytical method.
Test report
The test report shall include at least the following information.
- number of this Part;
- glove type and production batch number;
- name and address of the manufacturer or the supplier and laboratory (if different);
- test date;
- a description of the test method used;
- test results.
Annex A
(normative)
Method for determining water-soluble proteins of natural rubber gloves
by improved Lowry analytical method
A.1 Scope
This method is used to determine the mass of water-soluble proteins in medical gloves made of natural rubber. This method has been confirmed in the synergy test carried out between laboratories. The minimum detection limit of this method is approximately 10 ??g per gram of glove (i.e. 2 ??g protein per mL of extract), which depends on the weight of the glove.
Chemicals such as surfactants, catalysts and antioxidants that are added to natural rubber during the production process of gloves can interfere with the color development process. Some substances may reduce color development, while some may increase color development. If errors occur due to interference in the test, it may use any confirmed amino acid analytical method (such as the method given in Annex C).
NOTE. Persons using this method shall be familiar with the general laboratory procedures. This method does not involve safety issues. If the method of use involves such issues, the user is responsible for establishing corresponding safety and health regulations and ensuring that they are consistent with the requirements of the national regulations.
A.2 Principle
Water-soluble proteins are soaked in a kind of buffer solution, then add sodium deoxycholate, precipitate and concentrate with acid and separate from water- soluble substances (that may interfere with the test). The precipitated protein is re-dissolved in the base and colorimetrically quantified using the improved Lowry method. The principle of the analysis is basing on the characteristics that protein reacts with copper and Folin reagents in alkaline medium to form blue, use spectrophotometer to measure in the wavelength range of 600 nm to 750 nm.
A.3 Reagents
A.3.1 General
The test water shall be double distilled water or water of the same quality, all reagents shall be analytical regents.
A.3.2 Leaching media
A.3.2.1 N-tris-[Hydroxymethyl]-methyl-2-amioethanesulfonic acid (TES), N- tris(hydroxymethyl)methyl 2-aminoethane sulfonic acid (TES), hemisodium-salt. A.3.2.2 Leaching buffer solution, 0.1 mol/L. DISSOLVE 24 g of TES (A.3.2.1) in water and DILUTE to 1 L. Any equivalent buffer system that maintains the pH of the glove leaching solution at 7.4 ?? 0.2 can be used.
NOTE. Prepare a sufficient amount of glove leaching solution (A.6.2), protein standard solution (A.6.3.2) and blank solution.
A.3.2.3 Staining solution, sodium salt solution of bromophenol blue. DISSOLVE 100 mg of bromophenol blue with water and DILUTE to 1 L. Prepare fresh
solution every 4 weeks.
A.3.3 Lowry protein analysis kit
NOTE. The kit can be prepared using current chemicals [1], or kits can be purchased. The method in this Part is confirming with kits1).
A.3.3.1 Reagent A, copper reagent (alkaline tartrate or copper citrate solution). A.3.3.2 Reagent B, diluted Folin reagent.
A.3.4 Sodium hydroxide solution
[c(NaOH) = 0.1 mol//L].
A.3.5 Sodium deoxycholate (DOC)
DISSOLVE 0.15 g of sodium deoxycholate with water and DILUTE to 100 mL. The solution could not be used over 4 weeks after it was prepared.
A.3.6 Trichloroacetic acid (TCA)
4.4 mol/L aqueous solution, which is prepared by dissolving 72 g of TCA in water and diluting to 100 mL.
A.3.7 Phosphotungstic acid (PTA)
DISSOLVE 72 g PTA with water and DILUTE to 100 mL. The solution could not be used over 4 weeks after it was prepared.
A.3.8 Ovalbumin
1) The Lowry Micro DC Protein Assay Kit (Cat. No. 500-0116) is available from the BioRad Laboratory at 2000 Alfred Nobel Drive, Hercules, CA 9456547, USA. This information is only for the convenience of users of this Part and does not imply endorsement of this product.
Extracted from lyophilized eggs2), no salt.
A.4 Instruments
A.4.1 Synthetic gloves, no powder.
A.4.2 Centrifuge, with the centrifugal force can reach at least 6000 g. A.4.3 Centrifuge tube, 30 mL or 50 mL polypropylene tube. The protein binding capacity of the tube shall not exceed 10 ??g per tube. Do not use glassware because the surface absorbs proteins.
NOTE. A.5 gives a method to determine the protein binding capacity.
A.4.4 Filter membrane, disposable, with pore size of 0.22 ??m, and the protein binding capacity of each filter membrane does not exceed 10 ??g.
NOTE. A.5 gives a method to determine the protein binding capacity.
A.4.5 Syringe, disposable, 20 mL, made of polyethylene or polypropylene material.
A.4.6 Micro test tube, 2 mL, made of polypropylene material.
A.4.7 Quartz cuvette, with light path length of 1cm.
A.4.8 ELISA plate, 96 wells, flat bottom, made of polystyrene material, or disposable plate well (A.4.9).
A.4.9 Disposable plate well, 1.5 mL semi-micro type, with light path of length 1 cm, made of polystyrene material.
A.4.10 Microplate reader, with wavelength range of 600 nm ~ 750 nm.
A.4.11 Spectrophotometer, with wavelength range of 230 nm ~ 750 nm.
A.4.12 Vortex mixer.
A.4.13 Micropipette, with disposable polypropylene tip.
A.4.14 Fixture, used in the leaching process to seal gloves to prevent water leakage. It is recommended to use a foam-rubber-lined aluminum fixture (see Figure A.1) or a 170 mm long hemodialysis plastic fixture.
2) The ovalbumin is prepared by fractionation and repeated crystallization of ammonium sulfate at pH 4.5 using ammonium sulfate. For example, Sigma A5503, chicken protein, grade V, is available from Sigmar Chemical Co. P.O. Box 14506, St Louis, MO 63178, USA. This information is provided for users of this section only and does not imply endorsement of this product. Dimensions in millimeters
Key.

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